BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE

    MDR report key: 2952302 · Received February 9, 2013

    Report

    Report Number
    2183613-2013-00095
    Event Type
    Malfunction
    Date Received
    February 9, 2013
    Date of Event
    December 3, 2012
    Report Date
    December 7, 2012
    Manufacturer
    MEDTRONIC MILACA, INC.
    Product Code
    LWP
    PMA / PMN Number
    P820003/S072
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SD, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PRODUCT EVENT SUMMARY: ANALYSIS CONFIRMED THE REPORTED EVENT, THE HEART LEAD FLEX WAS OUT OF ELECTRICAL SPECIFICATION. AFTER FURTHER ANALYSIS WAS PERFORMED, IT WAS NOTED THAT WHILE MANUALLY PRESSING ON A CONNECTOR WHILE IN OPERATION THIS CORRECTED THE FAILURE. AFTER MAGNIFIED INSPECTION WAS PERFORMED IT WAS NOTED THAT THERE WAS AN OPEN HEART FLEX CIRCUIT AT THE A-RING LOCATION. THIS OPEN CIRCUIT PREVENTED PROPER SENSING OR PACING ON THE ATRIAL CHANNEL. (B)(4).

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. (B)(4).

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE DEVICE FAILED TESTING ON THE ATRIAL SIDE USING AN EXTERNAL PACING TESTER. THE DEVICE WAS RETURNED FOR REPAIR AND CALIBRATION. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THE DEVICE FAILED TESTING ON THE ATRIAL SIDE USING AN EXTERNAL PACING TESTER. THE DEVICE WAS RETURNED FOR REPAIR AND CALIBRATION. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    56485 PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE LWP MEDTRONIC MILACA, INC. 5388

    Patients

    Seq Age Sex Outcome Treatment
    1